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Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With DiverticulitisThe Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial

Educational Objective
Does elective sigmoid resection improve the quality of life in patients with recurrent diverticulitis, complicated diverticulitis, and/or chronic pain after an episode of diverticulitis?

1 Credit CME

JAMA Surgery

Published Online: November 18, 2020

Original Investigation

Article Information and Disclosures

Alexandre Santos, MD¹;

Panu Mentula, MD, PhD¹;

Tarja Pinta, MD, PhD²;

Shamel Ismail, MD¹;

Tero Rautio, MD, PhD³;

Risto Juusela, MD⁴;

Aleksi Lähdesmäki, MD, PhD⁵;

Tom Scheinin, MD, PhD¹;

Ville Sallinen, MD, PhD^1,6

Author Affiliations

¹Gastroenterological Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland
²Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland
³Department of Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland
⁴Department of Surgery, Vaasa Central Hospital, Vaasa, Finland
⁵Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland
⁶Transplantation and Liver Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland

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Key Points

Question Does elective sigmoid resection improve the quality of life in patients with recurrent diverticulitis, complicated diverticulitis, and/or chronic pain after an episode of diverticulitis?

Findings In this randomized clinical trial that included 85 adults, the Gastrointestinal Quality of Life Index (GIQLI) score improved 11.8 points in patients randomized to sigmoid resection and 0.2 points in patients randomized to conservative treatment between baseline and 6 months, a statistically and clinically significant difference. Among 41 patients randomized to sigmoid resection, 4 (10%) experienced major complications.

Meaning Sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but was associated with a small but significant risk of major complications.

Abstract

Importance Diverticulitis has a tendency to recur and affect quality of life.

Objective To assess whether sigmoid resection is superior to conservative treatment in improving quality of life of patients with recurrent, complicated, or persistent painful diverticulitis.

Design, Setting, and Participants This open-label randomized clinical trial assessed for eligibility 128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018. Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula. Outcomes were assessed using intention-to-treat analysis. A prespecified interim analysis was undertaken when 66 patients had been randomized and their 6-month follow-up was assessable. Data were analyzed from June 2018 to May 2020.

Interventions Laparoscopic sigmoid resection or conservative treatment.

Main Outcomes and Measures The primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between randomization and 6 months.

Results Of 128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13 [7.6] years). A total of 72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group). The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76 [15.89] points vs −0.2 [19.07] points; difference, 11.96; 95% CI, 3.72-20.19; P = .005). Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dindo grade III or higher). There were 2 patients (5%) in the surgery group and 12 patients (31%) in the conservative treatment group who had new episodes of diverticulitis within 6 months.

Conclusions and Relevance In this randomized clinical trial, elective laparoscopic sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications.

Trial Registration ClinicalTrials.gov Identifier: NCT02174926.

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Article Information

Accepted for Publication: August 1, 2020.

Published Online: November 18, 2020. doi:10.1001/jamasurg.2020.5151

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Santos A et al. JAMA Surgery.

Corresponding Author: Ville Sallinen, MD, PhD, Transplantation and Liver Surgery, University of Helsinki, Helsinki University Hospital, Haartmaninkatu 4, Helsinki, Finland 00029 (ville.sallinen@helsinki.fi).

Author Contributions: Drs Santos and Sallinen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Santos, Mentula, Scheinin, Sallinen.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Santos, Pinta, Sallinen.

Critical revision of the manuscript for important intellectual content: Santos, Mentula, Ismail, Rautio, Juusela, Lähdesmäki, Scheinin, Sallinen.

Statistical analysis: Santos, Sallinen.

Obtained funding: Santos, Sallinen.

Administrative, technical, or material support: Santos, Mentula, Pinta, Rautio, Juusela, Lähdesmäki, Scheinin, Sallinen.

Supervision: Mentula, Scheinin, Sallinen.

Conflict of Interest Disclosures: Dr Santos reports grants from The Finnish Medical Foundation during the conduct of the study. Dr Sallinen reports grants from Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, and Helsinki University Hospital research funds during the conduct of the study as well as grants from Academy of Finland, Finnish Cancer Foundation (Syöpäsäätiö), and Finnish Gastroenterological Society and personal fees from Finnish Gastroenterological Society, City of Vantaa, and University of Helsinki outside the submitted work. Dr Scheinin reports personal fees from Johnson & Johnson outside the submitted work. No other disclosures were reported.

Funding/Support: The study was funded by Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, The Finnish Medical Foundation, and Helsinki University Hospital research funds.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

References

Munie ST , Nalamati SPM . Epidemiology and pathophysiology of diverticular disease. Clin Colon Rectal Surg. 2018;31(4):209-213. doi:10.1055/s-0037-1607464 PubMed Google Scholar Crossref

Mali JP , Mentula PJ , Leppäniemi AK , Sallinen VJ . Symptomatic treatment for uncomplicated acute diverticulitis: a prospective cohort study. Dis Colon Rectum. 2016;59(6):529-534. doi:10.1097/DCR.0000000000000579 PubMed Google Scholar Crossref

Daniels L , Ünlü Ç , de Korte N , et al; Dutch Diverticular Disease (3D) Collaborative Study Group. Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis. Br J Surg. 2017;104(1):52-61. doi:10.1002/bjs.10309 PubMed Google Scholar Crossref

Chabok A , Påhlman L , Hjern F , Haapaniemi S , Smedh K ; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012;99(4):532-539. doi:10.1002/bjs.8688 PubMed Google Scholar Crossref

Sallinen VJ , Leppäniemi AK , Mentula PJ . Staging of acute diverticulitis based on clinical, radiologic, and physiologic parameters. J Trauma Acute Care Surg. 2015;78(3):543-551. doi:10.1097/TA.0000000000000540 PubMed Google Scholar Crossref

Sartelli M , Catena F , Moore EE , et al. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016;11(1):37. doi:10.1186/s13017-016-0095-0 PubMed Google Scholar Crossref

Wong WD , Wexner SD , Lowry A , et al; The American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of sigmoid diverticulitis—supporting documentation. Dis Colon Rectum. 2000;43(3):290-297. doi:10.1007/BF02258291 PubMed Google Scholar Crossref

Ritz JP , Lehmann KS , Frericks B , Stroux A , Buhr HJ , Holmer C . Outcome of patients with acute sigmoid diverticulitis: multivariate analysis of risk factors for free perforation. Surgery. 2011;149(5):606-613. doi:10.1016/j.surg.2010.10.005 PubMed Google Scholar Crossref

Chapman JR , Dozois EJ , Wolff BG , Gullerud RE , Larson DR . Diverticulitis: a progressive disease? do multiple recurrences predict less favorable outcomes? Ann Surg. 2006;243(6):876-830. doi:10.1097/01.sla.0000219682.98158.11 PubMed Google Scholar Crossref

Rafferty J , Shellito P , Hyman NH , Buie WD ; Standards Committee of American Society of Colon and Rectal Surgeons. Practice parameters for sigmoid diverticulitis. Dis Colon Rectum. 2006;49(7):939-944. doi:10.1007/s10350-006-0578-2 PubMed Google Scholar Crossref

Feingold D , Steele SR , Lee S , et al. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014;57(3):284-294. doi:10.1097/DCR.0000000000000075 PubMed Google Scholar Crossref

Sallinen V , Mali J , Leppäniemi A , Mentula P . Assessment of risk for recurrent diverticulitis: a proposal of risk score for complicated recurrence. Medicine. 2015;94(8):e557. doi:10.1097/MD.0000000000000557 PubMed Google Scholar

Gaertner WB , Willis DJ , Madoff RD , et al. Percutaneous drainage of colonic diverticular abscess: is colon resection necessary? Dis Colon Rectum. 2013;56(5):622-626. doi:10.1097/DCR.0b013e31828545e3 PubMed Google Scholar Crossref

van de Wall BJM , Draaisma WA , van Iersel JJ , Consten ECJ , Wiezer MJ , Broeders IAMJ . Elective resection for ongoing diverticular disease significantly improves quality of life. Dig Surg. 2013;30(3):190-197. doi:10.1159/000346482 PubMed Google Scholar Crossref

Forgione A , Leroy J , Cahill RA , et al. Prospective evaluation of functional outcome after laparoscopic sigmoid colectomy. Ann Surg. 2009;249(2):218-224. doi:10.1097/SLA.0b013e318195c5fc PubMed Google Scholar Crossref

Pasternak I , Wiedemann N , Basilicata G , Melcher GA . Gastrointestinal quality of life after laparoscopic-assisted sigmoidectomy for diverticular disease. Int J Colorectal Dis. 2012;27(6):781-787. doi:10.1007/s00384-011-1386-2 PubMed Google Scholar Crossref

Hall J , Hardiman K , Lee S , et al; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons clinical practice guidelines for the treatment of left-sided colonic diverticulitis. Dis Colon Rectum. 2020;63(6):728-747. doi:10.1097/DCR.0000000000001679 PubMed Google Scholar Crossref

van de Wall BJ , Draaisma WA , Consten EC , et al. Dutch Diverticular Disease. (3D) Collaborative Study Group. Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2016;2(1):13-22. doi:10.1016/S2468-1253(16)30109-1 PubMed Google Scholar Crossref

Bolkenstein HE , Consten ECJ , van der Palen J , et al; Dutch Diverticular Disease (3D) Collaborative Study Group. Long-term outcome of surgery versus conservative management for recurrent and ongoing complaints after an episode of diverticulitis: 5-year follow-up results of a multicenter randomized controlled trial (DIRECT-Trial). Ann Surg. 2019;269(4):612-620. doi:10.1097/SLA.0000000000003033 PubMed Google Scholar Crossref

Jayadevappa R , Cook R , Chhatre S . Minimal important difference to infer changes in health-related quality of life—a systematic review. J Clin Epidemiol. 2017;89:188-198. doi:10.1016/j.jclinepi.2017.06.009 PubMed Google Scholar Crossref

Taft C , Karlsson J , Sullivan M , Do. Do SF-36 summary component scores accurately summarize subscale scores? Qual Life Res. 2001;10(5):395-404. doi:10.1023/A:1012552211996 PubMed Google Scholar Crossref

Regenbogen SE , Hardiman KM , Hendren S , Morris AM . Surgery for diverticulitis in the 21st century: a systematic review. JAMA Surg. 2014;149(3):292-303. doi:10.1001/jamasurg.2013.5477 PubMed Google Scholar Crossref

van de Wall BJM , Draaisma WA , van Iersel JJ , Consten ECJ , Wiezer MJ , Broeders IAMJ . Elective resection for ongoing diverticular disease significantly improves quality of life. Dig Surg. 2013;30(3):190-197. doi:10.1159/000346482 PubMed Google Scholar Crossref

Andeweg CS , Berg R , Staal JB , ten Broek RP , van Goor H . Patient-reported outcomes after conservative or surgical management of recurrent and chronic complaints of diverticulitis: systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2016;14(2):183-190. doi:10.1016/j.cgh.2015.08.020 PubMed Google Scholar Crossref

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.