Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-09-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic or Recurrent Appendicitis

Keywords

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Abdominal pain Appendectomy Laparoscopy Chronic appendicitis Appendicopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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laparoscopic appendectomy or not (surgery)

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Rudi Roumen, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Maxima Medical Center

References

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de Kok HJ. Laparoscopic appendectomy: a new opportunity for curing appendicopathy. Surg Laparosc Endosc. 1992 Dec;2(4):297-302.

Reference Type BACKGROUND

PMID: 1341549 (View on PubMed)

Other Identifiers

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9335

Identifier Type: -

Identifier Source: org_study_id