Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

December 19, 2006 updated by: Maxima Medical Center

Elective Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain; Outcome of a Prospective Randomized Double-Blind Controlled Surgical Trial

It is questionable whether elective appendectomy can effectively reduce pain in persistent or recurrent lower abdominal quadrant pain due to chronic appendicitis.

A single centre randomised double-blind sham surgery controlled clinical trial studied the effects of elective laparoscopic appendectomy on postoperative pain perception in patients with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months postoperatively. Secondary outcome was the relation between clinical response and the appendix' histopathology. The analysis was performed on an intention-to-treat basis. Pain scores were compared using a Fisher's exact test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty patients were randomised, 18 patients had a laparoscopic appendectomy and 22 patients had a laparoscopic inspection only. The postoperative pain scores were significantly different favouring appendix removal (p < 0.01). Relative risk calculations indicated a 2.4 fold (95% CI: 1.3 - 4.0) greater chance of improving or becoming pain free after laparoscopic appendectomy. The number needed to treat was 2.2 patients (95% CI: 1.5 - 6.5). There was no significant relation between postoperative pain scores and histopathology findings.

Conclusions Chronic or recurrent appendicitis is a realistic clinical entity that can be treated successfully by elective appendectomy leading to significant pain reduction in properly selected cases. Histopathology of the removed appendix does not contribute to the diagnosis.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion.

Exclusion Criteria:

  • Exclusion criteria consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, exclusion was possible when diagnostic laparoscopy revealed abnormalities (see below).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary outcome: pain reduction
The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Secondary outcome: histopathology
The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maxima Medical Center

Investigators

  • Principal Investigator: Rudi Roumen, PhD, MD, Maxima Medical Center

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1994

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 20, 2006

Last Update Submitted That Met QC Criteria

December 19, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9335 (Duke legacy protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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