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1. Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial

Author

Andrea Fontana, Michela Mineccia, Serena Perotti, Claudia Galassi, Maria Carmela Giuffrida, Donatella Marino, Igor Monsellato, Myriam Katja Paris, Roberto Perinotti, Patrizia Racca, Chiara Monagheddu, Elisa Ponte, Massimiliano Mistrangelo, Francesco Tomaselli, Rossella Reddavid, Simone Birolo, Marcello Calabrò, Nicoletta Pipitone, Luca Panier Suffat, Francesco Potente, Domenico Piscioneri, Alberto Serventi, Luca Mazza, Paolo Bellora, Fabio Colli, Clemente De Rosa, and Renza Trapani

Subjects
Medicine
Abstract

Introduction Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer.Methods and analysis This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d’Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints.Ethics and dissemination The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients’ point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals.Trial registration number NCT04372992.

Published
2021
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2. High complication rate in Crohn's disease surgery following percutaneous drainage of intra-abdominal abscess: a multicentre study

Author

Celentano, Valerio, Giglio, Mariano Cesare, Pellino, Gianluca, Rottoli, Matteo, Sampietro, Gianluca, Spinelli, Antonino, Selvaggi, Francesco, Gilberto, Poggioli, Giuseppe, Sica, Michela, Campanelli, Claudio, Coco, Gianluca, Rizzo, Francesco, Sionne, Francesco, Colombo, Giulia, Lamperti, Diego, Foschi, Ferdinando, Ficari, Ludovica, Vacca, Marta, Cricchio, Francesco, Giudici, Lucio, Selvaggi, Sciaudone, Guido, Roberto, Peltrini, Andrea, Manfreda, Luigi, Bucci, Raffaele, Galleano, Omar, Ghazouani, Luigi, Zorcolo, Simona, Deidda, Angelo, Restivo, Andrea, Braini, Francesca Di Candido, Matteo, Sacchi, Michele, Carvello, Stefania, Martorana, Giovanni, Bordignon, Imerio, Angriman, Angela, Variola, Mirko Di Ruscio, Giuliano, Barugola, Andrea, Geccherle, Francesca Paola Tropeano, Gaetano, Luglio, Marta, Tanzanu, Diego, Sasia, Marco, Migliore, Maria Carmela Giuffrida, Enrico, Marrano, Gianluigi, Moretto, Harmony, Impellizzeri, Gaetano, Gallo, Giuseppina, Vescio, Giuseppe, Sammarco, Giovanni, Terrosu, Giacomo, Calini, Andrea, Bondurri, Anna Maffioli Md, Gloria, Zaffaroni, Andrea, Resegotti, Massimiliano, Mistrangelo, Marco Ettore Allaix, Fiorenzo, Botti, Matteo, Prati, Luigi, Boni, Serena, Perotti, Michela, Mineccia, Antonio, Giuliani, Lucia, Romano, Giorgio Maria Paolo Graziano, Luigi, Pugliese, Andrea, Pietrabissa, Gian Gaetano Delaini, Celentano, Valerio, Giglio, Mariano Cesare, Pellino, Gianluca, Rottoli, Matteo, Sampietro, Gianluca, Spinelli, Antonino, Selvaggi, Francesco, Luglio, Gaetano, and Valerio Celentano, Gianluca Pellino, Matteo Rottoli, Gilberto Poggioli, Giuseppe Sica, Mariano Cesare Giglio, Michela Campanelli, Claudio Coco, Gianluca Rizzo, Francesco Sionne, Francesco Colombo, Gianluca Sampietro, Giulia Lamperti, Diego Foschi, Ferdinando Ficari, Ludovica Vacca, Marta Cricchio, Francesco Giudici, Lucio Selvaggi, Guido Sciaudone, Roberto Peltrini, Andrea Manfreda, Luigi Bucci, Raffaele Galleano, Omar Ghazouani, Luigi Zorcolo, Simona Deidda, Angelo Restivo, Andrea Braini, Francesca Di Candido, Matteo Sacchi, Michele Carvello, Stefania Martorana, Giovanni Bordignon, Imerio Angriman, Angela Variola, Mirko Di Ruscio, Giuliano Barugola, Andrea Geccherle, Francesca Paola Tropeano, Gaetano Luglio, Marta Tanzanu, Diego Sasia, Marco Migliore, Maria Carmela Giuffrida, Enrico Marrano, Gianluigi Moretto, Harmony Impellizzeri, Gaetano Gallo, Giuseppina Vescio, Giuseppe Sammarco, Giovanni Terrosu, Giacomo Calini, Andrea Bondurri, Anna Maffioli Md, Gloria Zaffaroni, Andrea Resegotti, Massimiliano Mistrangelo, Marco Ettore Allaix, Fiorenzo Botti, Matteo Prati, Luigi Boni, Serena Perotti, Michela Mineccia, Antonio Giuliani, Lucia Romano, Giorgio Maria Paolo Graziano, Luigi Pugliese, Andrea Pietrabissa, Gian Gaetano Delaini, Antonino Spinelli, Francesco Selvaggi

Subjects
Crohn’s disease, Adult, Abdominal Abscess, Abdominal Absce, Gastroenterology, Anastomotic Leak, Intra-abdominal abscess, Inflammatory bowel disease, Settore MED/18, Settore MED/18 - Chirurgia Generale, Postoperative Complications, Crohn Disease, Colorectal surgery, Retrospective Studie, Colectomy, Drainage, Humans, Retrospective Studies, Intra-abdominal absce, Postoperative Complication, Human
Abstract

Introduction Intra-abdominal abscesses complicating Crohn’s disease (CD) present an additional challenge as their presence can contraindicate immunosuppressive treatment whilst emergency surgery is associated with high stoma rate and complications. Treatment options include a conservative approach, percutaneous drainage, and surgical intervention. The current multicentre study audited the short-term outcomes of patients who underwent preoperative radiological drainage of intra-abdominal abscesses up to 6 weeks prior to surgery for ileocolonic CD. Methods This is a retrospective, multicentre, observational study promoted by the Italian Society of Colorectal Surgery (SICCR), including all adults undergoing ileocolic resection for primary or recurrent CD from June 2018 to May 2019. The outcomes of patients who underwent radiological guided drainage prior to ileocolonic resection were compared to the patients who did not require preoperative drainage. Postoperative morbidity within 30 days of surgery was the primary endpoint. Postoperative length of hospital stay (LOS) and anastomotic leak rate were the secondary outcomes. Results Amongst a group of 575 included patients who had an ileocolic resection for CD, there were 36 patients (6.2%) who underwent abscess drainage prior to surgery. Postoperative morbidity (44.4%) and anastomotic leak (11.1%) were significantly higher in the group of patients who underwent preoperative drainage. Conclusions Patients with Crohn’s disease who require preoperative radiological guided drainage of intra-abdominal abscesses are at increased risk of postoperative morbidity and septic complications following ileocaecal or re-do ileocolic resection.

Published
2022

3. Has the Removing of the Mesentery during Ileo-Colic Resection an Impact on Post-Operative Complications and Recurrence in Crohn's Disease? Results from the Resection of the Mesentery Study (Remedy)

Author

Michela Mineccia, Giovanni Maconi, Marco Daperno, Maria Cigognini, Valeria Cherubini, Francesco Colombo, Serena Perotti, Caterina Baldi, Paolo Massucco, Sandro Ardizzone, Alessandro Ferrero, and Gianluca M. Sampietro

Subjects
IBD, Crohn’s disease, surgery, resection, anastomosis, mesentery, complications, surgical recurrence, General Medicine
Abstract

Some evidence suggests a reduction in clinical and surgical recurrence after mesenteric resection in Crohn’s Disease (CD). The aim of the REsection of the MEsentery StuDY (Remedy) was to assess whether mesenteric removal during surgery for ileocolic CD has an impact in terms of postoperative complications, endoscopic and ultrasonographic recurrences, and long-term surgical recurrence. Among the 326 patients undergoing primary resection between 2009 and 2019 in two referral centers, in 204 (62%) the mesentery was resected (Group A) and in 122 (38%) it was retained (Group B). Median follow-up was 4.7 ± 3 years. Groups were similar in the peri-operative course. Endoscopic and ultrasonographic recurrences were 44.6% and 40.4% in Group A, and 46.7% and 41.2% in Group B, respectively, without statistically significant differences. The five-year time-to-event estimates, compared with the Log-rank test, were 3% and 4% for normal or thickened mesentery (p = 0.6), 2.8% and 4% for resection or sparing of the mesentery (p = 0.6), and 1.7% and 5.4% in patients treated with biological or immunosuppressants versus other adjuvant therapy (p = 0.02). In Cox’s model, perforating behavior was a risk factor, and biological or immunosuppressant adjuvant therapy protective for surgical recurrence. The resection of the mesentery does not seem to reduce endoscopic and ultrasonographic recurrences, and the five-year recurrence rate.

Published
2022

4. Emergency colectomy for acute severe ulcerative colitis: a nationwide survey on technical strategies of the Italian society of colorectal surgery (SICCR)

Author

Michela Mineccia, Serena Perotti, Gianluca Pellino, Gianluca Matteo Sampietro, Valerio Celentano, Rodolfo Rocca, Marco Daperno, Alessandro Ferrero, Mineccia, Michela, Perotti, Serena, Pellino, Gianluca, Sampietro, Gianluca Matteo, Celentano, Valerio, Rocca, Rodolfo, Daperno, Marco, and Ferrero, Alessandro

Subjects
Acute severe ulcerative coliti, Emergency colectomy, Colic, Humans, Surgery, Laparoscopy, Colitis, Ulcerative, Operative guideline, Colorectal Surgery, Inflammatory bowel disease, Colectomy, Human, Mesocolon
Abstract

Emergency subtotal colectomy is the standard treatment for acute severe ulcerative colitis (ASUC) unresponsive to medical treatment. No guidelines are available about surgical technique. The aim of the current survey was to identify the attitudes of Inflammatory Bowel Disease (IBD) surgeons concerning colectomy in patients with ASUC by means of a nationwide survey, with specific focus on intraoperative technical details. A survey was developed with focus on number of procedures performed, approach to vascular ligation, technique of bowel dissection, treatment of the omentum and of the rectal stump. Twenty Centres completed the survey. Seventy percent of responders started the colectomy laparoscopically. No significant differences were observed about vessels and mesocolic dissection as well as on the choice of the starting colon side and management of the omentum. Ileocolic vessels were ligated distally by 70% and at the origin by 30% and those who transect mesenteric vessels distally are significatively more likely to perform the dissection from lateral to medial and to cut the middle colic vessels distally and 100% of the ones linking left vessels at mesenteric axis transect middle colic vessels at the origin. No differences were observed in the treatment of rectal stump; however, all surgeons who performed a transrectal drainage (45%) left the rectal stump intraperitoneal (p < 0.05). No consensus exists about the technique of dissection, vascular ligation, treatment of the omentum and management of rectal stump. Further studies are needed to evaluate the impact of the different surgical techniques on patients' outcomes.

Published
2022

5. Single-incision laparoscopic surgery (SILS) for the treatment of ileocolonic Crohn’s disease: a propensity score–matched analysis

Author

Celentano, V, Pellino, G, Rottoli, M, Colombo, F, Sampietro, G, Spinelli, A, Selvaggi, F, Valerio Celentano, SICCR Current status of Crohn’s disease surgery collaborative., Gianluca, Pellino, Matteo, Rottoli, Poggioli, Gilberto, Giuseppe, Sica, Mariano Cesare Giglio, Michela, Campanelli, Claudio, Coco, Gianluca, Rizzo, Francesco, Sionne, Francesco, Colombo, Gianluca, Sampietro, Giulia, Lamperti, Diego, Foschi, Ferdinando, Ficari, Ludovica, Vacca, Marta, Cricchio, Francesco, Giudici, Lucio, Selvaggi, Guido, Sciaudone, Roberto, Peltrini, Andrea, Manfreda, Luigi, Bucci, Raffaele, Galleano, Omar, Ghazouani, Luigi, Zorcolo, Simona, Deidda, Angelo, Restivo, Andrea, Braini, Francesca Di Candido, Matteo, Sacchi, Michele, Carvello, Stefania, Martorana, Giovanni, Bordignon, Imerio, Angriman, Angela, Variola, Mirko Di Ruscio, Giuliano, Barugola, Andrea, Geccherle, Francesca Paola Tropeano, Gaetano, Luglio, Marta, Tanzanu, Sasia, Diego, Migliore, Marco, Maria Carmela Giuffrida, Enrico, Marrano, Gianluigi, Moretto, Harmony, Impellizzeri, Gaetano, Gallo, Giuseppina, Vescio, Giuseppe, Sammarco, Giovanni, Terrosu, Giacomo, Calini, Andrea, Bondurri, Anna, Maffioli, Gloria, Zaffaroni, Andrea, Resegotti, Mistrangelo, Massimiliano, Allaix, Marco Ettore, Fiorenzo, Botti, Matteo, Prati, Luigi, Boni, Serena, Perotti, Mineccia, Michela, Antonio, Giuliani, Lucia, Romano, Giorgio Maria Paolo Graziano, Luigi, Pugliese, Andrea, Pietrabissa, Giangaetano, Delaini, Antonino, Spinelli, Francesco, Selvaggi, Celentano, V., Pellino, G., Rottoli, M., Colombo, F., Sampietro, G., Spinelli, A., Selvaggi, F., Poggioli, G., Sica, G., Giglio, M. C., Campanelli, M., Coco, C., Rizzo, G., Sionne, F., Lamperti, G., Foschi, D., Ficari, F., Vacca, L., Cricchio, M., Giudici, F., Selvaggi, L., Sciaudone, G., Peltrini, R., Manfreda, A., Bucci, L., Galleano, R., Ghazouani, O., Zorcolo, L., Deidda, S., Restivo, A., Braini, A., Di Candido, F., Sacchi, M., Carvello, M., Martorana, S., Bordignon, G., Angriman, I., Variola, A., Di Ruscio, M., Barugola, G., Geccherle, A., Tropeano, F. P., Luglio, G., Tanzanu, M., Sasia, D., Migliore, M., Giuffrida, M. C., Marrano, E., Moretto, G., Impellizzeri, H., Gallo, G., Vescio, G., Sammarco, G., Terrosu, G., Calini, G., Bondurri, A., Maffioli, A., Zaffaroni, G., Resegotti, A., Mistrangelo, M., Allaix, M. E., Botti, F., Prati, M., Boni, L., Perotti, S., Mineccia, M., Giuliani, A., Romano, L., Graziano, G. M. P., Pugliese, L., Pietrabissa, A., Delaini, G. G., Celentano, Valerio, Pellino, Gianluca, Rottoli, Matteo, Colombo, Francesco, Sampietro, Gianluca, Poggioli, Gilberto, Spinelli, Antonino, and Selvaggi, Francesco

Subjects
Crohn’s disease, Tumor Necrosis Factor Inhibitor, Short Communication, tumor necrosis factor inhibitors, Inflammatory Bowel Disease, Gastroenterology, inflammatory bowel sisease, Length of Stay, Single-incision laparoscopic surgery . Inflammatory BowelDisease . Crohn’s disease, single-incision laparoscopic surgery, humans, length of stay, postoperative complications, propensity score, retrospective studies, treatment outcome, Crohn disease, laparoscopy, 03 medical and health sciences, 0302 clinical medicine, Treatment Outcome, Crohn Disease, Single-incision laparoscopic surgery, Retrospective Studie, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Laparoscopy, Postoperative Complication, Propensity Score, Human
Abstract

Introduction Single-incision laparoscopic surgery (SILS) aims to minimize the surgical access trauma by reducing the number of abdominal incisions to a single site, potentially offering better cosmetic results and decreased postoperative pain. In this study, we compare the results of SILS ileocolic resection for Crohn’s disease (CD) to conventional laparoscopy and open surgery using a propensity score–matched analysis in a retrospective national multicentre study. Methods All consecutive patients undergoing elective SILS ileocaecal or redo ileocolic resection for primary and recurrent CD from 1 June 2018 to 31 May 2019 were included. Patients were matched 1:1:1 with laparoscopy and open surgery according to perianal disease, recurrent disease, penetrating phenotype of CD, history of previous abdominal surgery, preoperative medical treatment with steroids and anti-TNF. Postoperative morbidity within 30 days of surgery was the primary endpoint. Results Fifty-eight patients were included in each group, for a total of 174 patients. The conversion rate for SILS and laparoscopy was 10.3% and 12%, respectively, with no difference in the incidence of postoperative complications (13.8% and 12%, p = 0.77), whilst open surgery demonstrated a worse morbidity profile, with a complication rate of 25.9% (p < 0.0001). Median length of hospital stay following SILS ileocolic resection was 5 days, significantly shorter compared to 7 days for laparoscopy and 9 for open surgery (p < 0.0001). Conclusions SILS ileocolonic resection for CD demonstrated a comparable morbidity profile compared to laparoscopy in selected patients, with a reduced length of postoperative hospital stay.

Published
2021

6. Correction to: Surgical treatment of colonic Crohn's disease: a national snapshot study

Author

Gianluca M. Sampietro, Serena Perotti, A Geccherle, Andrea Braini, Mariano Cesare Giglio, Anna Maffioli, Antonino Spinelli, Valerio Celentano, Diego Sasia, Andrea Resegotti, Omar Ghazouani, Enrico Marrano, Angela Variola, Lucio Selvaggi, Marta Cricchio, G. Delaini, Marta Tanzanu, G Vescio, F. Sionne, Luigi Boni, Fiorenzo Botti, G. Rizzo, Andrea Pietrabissa, Claudio Coco, Gloria Zaffaroni, Roberto Peltrini, Ferdinando Ficari, Marco E. Allaix, Harmony Impellizzeri, Lucia Romano, A. Bondurri, Gaetano Gallo, Matteo Rottoli, Gaetano Luglio, Giacomo Calini, Giuseppe S. Sica, Giovanni Terrosu, M. Prati, Andrea Manfreda, Gilberto Poggioli, Luigi Pugliese, Giulia Lamperti, Ludovica Vacca, Michele Carvello, Francesca Paola Tropeano, Luigi Bucci, Francesco Colombo, Michela Mineccia, Diego Foschi, Matteo Sacchi, Imerio Angriman, Giovanni Bordignon, Luigi Zorcolo, Francesco Selvaggi, Angelo Restivo, Raffaele Galleano, Stefania Martorana, Gianluigi Moretto, Giorgio Maria Paolo Graziano, Marco Migliore, Maria Carmela Giuffrida, Giuseppe Sammarco, Massimiliano Mistrangelo, Guido Sciaudone, Gianluca Pellino, S. Deidda, Francesca Di Candido, Antonio Giuliani, Mirko Di Ruscio, Michela Campanelli, Giuliano Barugola, Francesco Giudici, Celentano, Valerio, Pellino, Gianluca, Rottoli, Matteo, Poggioli, Gilberto, Sica, Giuseppe, Giglio, Mariano Cesare, Campanelli, Michela, Coco, Claudio, Rizzo, Gianluca, Sionne, Francesco, Colombo, Francesco, Sampietro, Gianluca, Lamperti, Giulia, Foschi, Diego, Ficari, Ferdinando, Vacca, Ludovica, Cricchio, Marta, Giudici, Francesco, Selvaggi, Lucio, Sciaudone, Guido, Peltrini, Roberto, Manfreda, Andrea, Bucci, Luigi, Galleano, Raffaele, Ghazouani, Omar, Zorcolo, Luigi, Deidda, Simona, Restivo, Angelo, Braini, Andrea, Di Candido, Francesca, Sacchi, Matteo, Carvello, Michele, Martorana, Stefania, Bordignon, Giovanni, Angriman, Imerio, Variola, Angela, Barugola, Giuliano, Di Ruscio, Mirko, Tanzanu, Marta, Geccherle, Andrea, Tropeano, Francesca Paola, Luglio, Gaetano, Sasia, Diego, Migliore, Marco, Giuffrida, Maria Carmela, Marrano, Enrico, Moretto, Gianluigi, Impellizzeri, Harmony, Gallo, Gaetano, Vescio, Giuseppina, Sammarco, Giuseppe, Terrosu, Giovanni, Calini, Giacomo, Bondurri, Andrea, Maffioli, Anna, Zaffaroni, Gloria, Resegotti, Andrea, Mistrangelo, Massimiliano, Allaix, Marco Ettore, Botti, Fiorenzo, Prati, Matteo, Boni, Luigi, Perotti, Serena, Mineccia, Michela, Giuliani, Antonio, Romano, Lucia, Graziano, Giorgio Maria Paolo, Pugliese, Luigi, Pietrabissa, Andrea, Delaini, Giangaetano, Spinelli, Antonino, and Selvaggi, Francesco

Subjects
medicine.medical_specialty, Colonic Crohn's disease, business.industry, Crohn’s disease . Crohn’s colitis . Inflammatory bowel disease . Segmental colectomy . Proctocolectomy . National audit, General surgery, Vascular surgery, Cardiac surgery, Snapshot (photography), Cardiothoracic surgery, medicine, Surgery, business, Surgical treatment, Abdominal surgery
Published
2021

9. Correction to: Single-incision laparoscopic surgery (SILS) for the treatment of ileocolonic Crohn’s disease: a propensity score–matched analysis

Author

A. Bondurri, Mariano Cesare Giglio, Giulia Lamperti, S. Deidda, Antonino Spinelli, Serena Perotti, Gianluigi Moretto, Ferdinando Ficari, Gaetano Gallo, Francesco Selvaggi, Guido Sciaudone, Giorgio Maria Paolo Graziano, Massimiliano Mistrangelo, Angela Variola, Lucia Romano, Matteo Rottoli, Giuseppe S. Sica, Gianluca M. Sampietro, Michela Campanelli, Andrea Manfreda, M. Carvello, Gianluca Pellino, Diego Foschi, Andrea Pietrabissa, Luigi Boni, Roberto Peltrini, Matteo Sacchi, Stefania Martorana, G. Rizzo, Giacomo Calini, Imerio Angriman, Giovanni Bordignon, Omar Ghazouani, Francesca Paola Tropeano, Marco Migliore, F. Sionne, A Geccherle, Maria Carmela Giuffrida, Harmony Impellizzeri, Giuliano Barugola, Francesco Giudici, Luigi Bucci, Francesco Colombo, Giuseppe Sammarco, Angelo Restivo, Gaetano Luglio, Gloria Zaffaroni, Luigi Pugliese, M. Prati, Andrea Braini, M. Di Ruscio, Anna Maffioli, Gilberto Poggioli, Diego Sasia, G. Delaini, Antonio Giuliani, Lucio Selvaggi, Andrea Resegotti, Fiorenzo Botti, Raffaele Galleano, Valerio Celentano, Claudio Coco, Ludovica Vacca, Luigi Zorcolo, Marta Cricchio, Michela Mineccia, Giovanni Terrosu, F. Di Candido, Enrico Marrano, G Vescio, Marco E. Allaix, and Marta Tanzanu

Subjects
Laparoscopic surgery, medicine.medical_specialty, medicine.medical_treatment, Inflammatory bowel disease, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Crohn Disease, medicine, Clinical endpoint, Humans, Propensity Score, Laparoscopy, Retrospective Studies, Crohn's disease, medicine.diagnostic_test, business.industry, Incidence (epidemiology), Gastroenterology, Correction, Length of Stay, medicine.disease, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, Propensity score matching, Tumor Necrosis Factor Inhibitors, 030211 gastroenterology & hepatology, business, Abdominal surgery
Abstract

Single-incision laparoscopic surgery (SILS) aims to minimize the surgical access trauma by reducing the number of abdominal incisions to a single site, potentially offering better cosmetic results and decreased postoperative pain. In this study, we compare the results of SILS ileocolic resection for Crohn’s disease (CD) to conventional laparoscopy and open surgery using a propensity score–matched analysis in a retrospective national multicentre study. All consecutive patients undergoing elective SILS ileocaecal or redo ileocolic resection for primary and recurrent CD from 1 June 2018 to 31 May 2019 were included. Patients were matched 1:1:1 with laparoscopy and open surgery according to perianal disease, recurrent disease, penetrating phenotype of CD, history of previous abdominal surgery, preoperative medical treatment with steroids and anti-TNF. Postoperative morbidity within 30 days of surgery was the primary endpoint. Fifty-eight patients were included in each group, for a total of 174 patients. The conversion rate for SILS and laparoscopy was 10.3% and 12%, respectively, with no difference in the incidence of postoperative complications (13.8% and 12%, p = 0.77), whilst open surgery demonstrated a worse morbidity profile, with a complication rate of 25.9% (p < 0.0001). Median length of hospital stay following SILS ileocolic resection was 5 days, significantly shorter compared to 7 days for laparoscopy and 9 for open surgery (p < 0.0001). SILS ileocolonic resection for CD demonstrated a comparable morbidity profile compared to laparoscopy in selected patients, with a reduced length of postoperative hospital stay.

Published
2021

14. Laparoscopic bridging vs. anatomic open reconstruction for midline abdominal hernia mesh repair [LABOR]: single-blinded, multicenter, randomized, controlled trial on long-term functional results

Author

Fabrizio Lazzara, Denise Palombo, Umberto Bracale, Maria Santina Bruno, Stefano Pezzato, Tommaso Testa, Mikaela Imperatore, Cesare Stabilini, Gian Marco Rosa, Nicola Morelli, Serena Perotti, Marco Casaccia, Carolina Righetti, Marco Frascio, Rosario Fornaro, Giusto Pignata, Alessio Signori, Paolo Pelosi, Ezio Gianetta, Stabilini, C, Bracale, Umberto, Pignata, G, Frascio, M, Casaccia, M, Pelosi, P, Signori, A, Testa, T, Rosa, Gm, Morelli, N, Fornaro, R, Palombo, D, Perotti, S, Bruno, M, Imperatore, M, Righetti, C, Pezzato, S, Lazzara, F, and Gianetta, E.

Subjects
medicine.medical_specialty, Midline, Bridging (networking), Hernia, Time Factors, Incisional, Abdominal Hernia, Randomized, Medicine (miscellaneous), law.invention, Abdominal wall, Study Protocol, Postoperative Complications, Randomized controlled trial, Clinical Protocols, law, Recurrence, Functional results, Medicine, Humans, Single-Blind Method, Pharmacology (medical), Prospective Studies, Laparoscopy, Incisional, Midline, Hernia, Laparoscopy, Mesh, Functional results, Rives, Randomized, Herniorrhaphy, Mesh, Mesh repair, medicine.diagnostic_test, business.industry, Rives, Equipment Design, Middle Aged, Surgical Mesh, medicine.disease, Surgery, Hernia, Abdominal, Surgical mesh, medicine.anatomical_structure, Treatment Outcome, Italy, Research Design, Quality of Life, business
Abstract

BACKGROUND: Re-approximation of the rectal muscles along the midline is recommended by some groups as a rule for incisional and ventral hernia repairs. The introduction of laparoscopic repair has generated a debate because it is not aimed at restoring abdominal wall integrity but instead aims just to bridge the defect. Whether restoration of the abdominal integrity has a real impact on patient mobility is questionable, and the available literature provides no definitive answer. The present study aims to compare the functional results of laparoscopic bridging with those of re-approximation of the rectal muscle in the midline as a mesh repair for ventral and incisional abdominal defect through an "open" access. We hypothesized that, for the type of defect suitable for a laparoscopic bridging, the effect of an anatomical reconstruction is near negligible, thus not a fixed rule. METHODS AND DESIGN: The LABOR trial is a multicenter, prospective, two-arm, single-blinded, randomized trial. Patients of more than 60 years of age with a defect of less than 10 cm at its greatest diameter will be randomly submitted to open Rives or laparoscopic defect repair. All the participating patients will have a preoperative evaluation of their abdominal wall strength and mobility along with volumetry, respiratory function test, intraabdominal pressure and quality of life assessment.The primary outcome will be the difference in abdominal wall strength as measured by a double leg-lowering test performed at 12 months postoperatively. The secondary outcomes will be the rate of recurrence and changes in baseline abdominal mobility, respiratory function tests, intraabdominal pressure, CT volumetry and quality of life at 6 and 12 months postoperatively. DISCUSSION: The study will help to define the most suitable treatment for small-medium incisional and primary hernias in patients older than 60 years. Given a similar mid-term recurrence rate in both groups, if the trial shows no differences among treatments (acceptance of the null-hypothesis), then the choice of whether to submit a patient to one intervention will be made on the basis of cost and the surgeon's experience. TRIAL REGISTRATION: Current Controlled Trials ISRCTN93729016.

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