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Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

Primary Purpose

Chronic or Recurrent Appendicitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

laparoscopic appendectomy or not (surgery)

About this trial

This is an interventional treatment trial for Chronic or Recurrent Appendicitis focused on measuring Abdominal pain, Appendectomy, Laparoscopy, Chronic appendicitis, Appendicopathy

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Outcomes

Primary Outcome Measures

Primary outcome: pain reduction

The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively

Secondary Outcome Measures

Secondary outcome: histopathology

The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices

Full Information

NCT ID

NCT00413855

First Posted

December 19, 2006

Last Updated

December 19, 2006

Sponsor

Maxima Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00413855

Brief Title

Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Completed

Study Start Date

September 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Maxima Medical Center

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic or Recurrent Appendicitis

Keywords

Abdominal pain, Appendectomy, Laparoscopy, Chronic appendicitis, Appendicopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

laparoscopic appendectomy or not (surgery)

Primary Outcome Measure Information:

Title

Primary outcome: pain reduction

Title

The primary outcome measure was pain scored by the blinded patient at 6 months postoperatively

Secondary Outcome Measure Information:

Title

Secondary outcome: histopathology

Title

The secondary outcome parameter was the relation between clinical improvement and histopathological findings of the removed appendices

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudi Roumen, PhD, MD

Organizational Affiliation

Maxima Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

1341549

Citation

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

Results Reference

background

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Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

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