Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited

Chronic Pain Clinical Trial

Official title:

Laparoscopic Adhesiolysis for Chronic Abdominal Pain Revisited

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983916
• Other study ID #: RU-RTB-0005
• Status: Completed
• Start date: January 2015
• Est. completion date: March 2018

Study information

• Verified date: November 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Laparoscopic adhesiolysis for chronic abdominal pain revisited.

Background Prevalence of chronic pain following abdominal surgery may be as high as 40%. Postoperative chronic pain can be caused by various reasons, but adhesions are identified as the most likely cause in more 60% of cases. Early studies of adhesiolysis reported high success rates, up to 80%, in patients with no other cause of pain. Nonetheless, adhesiolysis is now seldom used in the treatment of chronic abdominal pain. Controversy over laparoscopic adhesiolysis as treatment for abdominal pain was raised by the landmark trial of Swank et al. In this trial 100 patients were randomized after the diagnosis of adhesions was confirmed laparoscopy between adhesiolysis or diagnostic laparoscopy alone. In the adhesiolysis group 57% of patients reported long-term pain relief vs. 42% in the diagnostic group; this difference was not statistically significant. The authors concluded that adhesiolysis was not effective, and thereafter many surgeons discarded adhesiolysis as treatment for chronic abdominal pain.

However, there are some important critiques on this trial. First, a type II error by too low sample size cannot be excluded. Second, some experimental studies indicate that filmy adhesions, which may be disrupted by pneumoperitoneum in the control patient group, cause most pain. Third, adhesions might have reformed after adhesiolysis, diminishing long term effects in the adhesiolysis group. Adhesion formation and reformation can effectively be reduced by application of an anti-adhesion barrier. Apart from these critiques, there is no evidence for effective alternative treatments.

Patients with chronic postoperative pain are frequently referred to the outpatient clinical of the surgery department of the RadboudUMC for expert opinion. Since 2012 the investigators started a 'patient participation in care' project for this patient group, in which laparoscopic adhesiolysis was reintroduced as treatment for chronic abdominal in selected cases. Cine- MRI was used as a novel non-invasive tool to diagnose adhesions, waiving the need for a negative laparoscopy in patient with other causes for chronic abdominal pain. Cine- MRI was recently developed as a non-invasive diagnostic tool to detect symptomatic adhesions, with reported sensitivity between 85%- 89% and specificity between 93%-95%. Decision for operative treatment was made based on individualized assessment of benefits and risks based on cine-MRI results in a shared-decision approach. Further, all patients undergoing adhesiolysis were treated with an anti-adhesion barrier.

Purpose & Research question The aim of this study is to evaluate the results of this novel shared decision approach using cine-MRI in a cohort of patients referred to the outpatient clinical of the department of surgery with chronic postoperative pain. Comparison is made between patients undergoing laparoscopic adhesiolysis, patients conservatively treated with adhesions on cine-MRI, and patients with no adhesions on cine-MRI.

Patients: Patients with chronic postoperative pain (>6 months) caused by adhesions as proven by cine-MRI Intervention: Laparoscopic adhesiolysis with adhesion barrier Controls: - control group 1: Patients with chronic postoperative pain and cine-MRI proven adhesions who had conservative treatment - Control group 2 patients with alternative diagnosis who had conservative treatment Outcome: • Change in symptoms (measured by Patients' Global Impression of Change scale), current pain (measured by numeric rate scale), Healthcare utilization (hospital visits, paramedic visits, medication)

Plan of investigation We will perform an analysis in a cohort of approximately 100 patients who underwent Cine-MRI in the work-up for chronic abdominal pain. Adhesions were identified in approximately 80 of the patients, 40 of them were operated and underwent laparoscopic adhesiolysis (group 1). The other 40 patients waived operation for various reasons and received conservative treatment (group 2). Patients with negative cine-MRI are analyzed as group 3. In a few cases a diagnostic laparoscopy was performed in case history, physical examination and cine-MRI were inconclusive. These patients will be analyzed as part of group 1.

Patients will be asked to participate in this study by telephone or letter. If agreed, a questionnaire will be sent comparing pain, improvement of pain since treatment, use of analgesics and other healthcare utilization between the operated and non-operated groups. Further data on the operation and peri-operative complications are gathered from the case records. Primary outcome is reduction or alleviation of pain. Secondary outcomes are current pain score (measured by VAS), analgesics use and healthcare utilization. Additional secondary outcomes for the operatively treated group are the incidence of conversion to open surgery, and peri-operative complications.

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

Inclusion criteria are :

• Age ≥ 18 years

• Pain exists for at least 6 months postoperatively

Exclusion criteria are:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria are :

• Age = 18 years

• Pain exists for at least 6 months postoperatively

Exclusion criteria are:

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

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Tissue Adhesion
• Tissue Adhesions

Intervention

Procedure:
• Adhesiolysis
Diagnostic laparoscopy or laparotomy with lysis of adhesions.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. — View Citation

Gerner-Rasmussen J, Burcharth J, Gögenur 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. Review. — View Citation

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. Erratum in: Lancet. 2003 Jun;361(9376):2250. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	measured by a verbal rating pain change scale (VRCS)	long-term >6 months to 3 years following surgery or cineMRI
Secondary	Current pain	measured by visual analogue scale (VAS)	long-term >6 months to 3 years following surgery or cineMRI
Secondary	Frequency of pain	measured by a questionnaire using a seven-point Likert scale	long-term >6 months to 3 years following surgery or cineMRI
Secondary	Daily discomfort	measured by a questionnaire using a seven-point Likert scale	long-term >6 months to 3 years following surgery or cineMRI
Secondary	Healthcare utilization	measured by the number of visits to the general practitioner, medical specialist, paramedics and complementary practitioners	long-term >6 months to 3 years following surgery or cineMRI
Secondary	Complications of surgery/ adhesiolysis	registered and graded according to the Clavien-Dindo classification. Complications scored as Clavien-Dindo grade 3 or higher were considered severe complications.	Peri-operative (up to 30 days after adhesiolysis)