Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited

NCT02983916 | Completed

• 1 other identifier: RU-RTB-0005
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic abdominal and pelvic pain is a common complaint following peritoneal surgery, affecting 20-40% of patients. Adhesions account for 60% of chronic postoperative pain cases, suggesting that adhesiolysis can play an important role in the management of such pain. Despite initial promising results regarding the effect of adhesiolysis on post-operative pain, implementation of the procedure has been challenging. The major problems associated with adhesiolysis for pain are recurrence of pain, need for invasive diagnosis with high rates of 'negative' laparoscopies, and inadvertent bowel injury during surgery. However, diagnosis and treatment of adhesions may be improved through the use of novel cine-MRI techniques, and with application of anti-adhesion barriers following adhesiolysis. In this study the investigators evaluate a new practice-based approach to the problem of chronic post-operative pain caused by adhesions. This practice-based approach includes use of a novel imaging technique for adhesions (cine-MRI) and shared decision making. Cine-MRI holds promise to diagnose and map adhesions. Thus patients with no adhesions, or high risk for bowel injury, can be waived from surgical treatment. By using anti-adhesion barriers the investigators attempt to prevent adhesion reformation and improve long-term outcomes of adhesiolysis.

Conditions

Chronic Pain; Tissue Adhesion

Keywords

Adhesions; Adhesiolysis; chronic pain; post-operative complications; anti-adhesion barrier; cine-MRI; shared decision making

Outcome Measures

Primary Outcomes (1)

• Change in pain

  measured by a verbal rating pain change scale (VRCS)

  long-term >6 months to 3 years following surgery or cineMRI

Secondary Outcomes (5)

• Current pain

  long-term >6 months to 3 years following surgery or cineMRI

• Frequency of pain

  long-term >6 months to 3 years following surgery or cineMRI

• Daily discomfort

  long-term >6 months to 3 years following surgery or cineMRI

• Healthcare utilization

  long-term >6 months to 3 years following surgery or cineMRI

• Complications of surgery/ adhesiolysis

  Peri-operative (up to 30 days after adhesiolysis)

Study Arms (3)

Group 1: adhesiolysis

Group 1 (the operative group) consisted of all patients who underwent laparoscopy and/or laparotomy. Typically patients had positive cine-MRI. A few patients with inconclusive cine-MRI who underwent diagnostic laparoscopy are also included in this group. Patients with no adhesions found during operation remain in group 1, because analysis is performed on intention-to-treat basis.

Procedure: Adhesiolysis

Group 2: Adhesions, conservative

Patients with evidence of adhesions based on cine-MRI who did not undergo laparoscopy or laparotomy.

Group 3: No adhesions

Patients in whom no evidence of adhesions was found on cine-MRI, and who did not undergo laparoscopy or laparotomy .

Interventions

Adhesiolysis PROCEDURE

Diagnostic laparoscopy or laparotomy with lysis of adhesions.

Group 1: adhesiolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the outpatient clinic of the department of surgery for chronic postoperative pain who underwent a cine-MRI are screened for eligibility.

You may qualify if:

• Age ≥ 18 years
• Pain exists for at least 6 months postoperatively

You may not qualify if:

• \- Cine-MRI not performed for chronic pain (e.g. recurrent pain with episodes of bowel obstructions)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Rijnstate Hospital: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800TA, Netherlands

Location

Related Publications (6)

• ten Broek RP, Bakkum EA, Laarhoven CJ, van Goor H. Epidemiology and Prevention of Postsurgical Adhesions Revisited. Ann Surg. 2016 Jan;263(1):12-9. doi: 10.1097/SLA.0000000000001286.

  PMID: 26135678 BACKGROUND

• Ten Broek RPG, Stommel MWJ, Strik C, van Laarhoven CJHM, Keus F, van Goor H. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. Lancet. 2014 Jan 4;383(9911):48-59. doi: 10.1016/S0140-6736(13)61687-6. Epub 2013 Sep 27.

  PMID: 24075279 BACKGROUND

• Gerner-Rasmussen J, Burcharth J, Gogenur I. The efficacy of adhesiolysis on chronic abdominal pain: a systematic review. Langenbecks Arch Surg. 2015 Jul;400(5):567-76. doi: 10.1007/s00423-015-1316-9. Epub 2015 Jun 20.

  PMID: 26088873 BACKGROUND

• Swank DJ, Swank-Bordewijk SC, Hop WC, van Erp WF, Janssen IM, Bonjer HJ, Jeekel J. Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi-centre trial. Lancet. 2003 Apr 12;361(9365):1247-51. doi: 10.1016/s0140-6736(03)12979-0.

  PMID: 12699951 BACKGROUND

• Cheong YC, Reading I, Bailey S, Sadek K, Ledger W, Li TC. Should women with chronic pelvic pain have adhesiolysis? BMC Womens Health. 2014 Mar 4;14(1):36. doi: 10.1186/1472-6874-14-36.

  PMID: 24588989 BACKGROUND

• van den Beukel BAW, Stommel MWJ, van Leuven S, Strik C, IJsseldijk MA, Joosten F, van Goor H, Ten Broek RPG. A Shared Decision Approach to Chronic Abdominal Pain Based on Cine-MRI: A Prospective Cohort Study. Am J Gastroenterol. 2018 Aug;113(8):1229-1237. doi: 10.1038/s41395-018-0158-9. Epub 2018 Jun 27.

  PMID: 29946174 RESULT

MeSH Terms

Conditions

Chronic Pain; Tissue Adhesions

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cicatrix; Fibrosis; Pathologic Processes

Study Officials

• Harry van Goor, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 6, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2018
• Last Updated: May 6, 2019

Record last verified: 2016-11

Locations

NL (1)