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Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413855
First Posted: December 20, 2006
Last Update Posted: December 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maxima Medical Center
  Purpose

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.


Condition Intervention Phase
Chronic or Recurrent Appendicitis Procedure: laparoscopic appendectomy or not (surgery) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Elective Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain; Outcome of a Prospective Randomized Double-Blind Controlled Surgical Trial

Resource links provided by NLM:


Further study details as provided by Maxima Medical Center:

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

Estimated Enrollment: 40
Study Start Date: September 1994
Estimated Study Completion Date: June 2005
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.

  Eligibility

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413855


Sponsors and Collaborators
Maxima Medical Center
Investigators
Principal Investigator: Rudi Roumen, PhD, MD Maxima Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00413855     History of Changes
Other Study ID Numbers: 9335
First Submitted: December 19, 2006
First Posted: December 20, 2006
Last Update Posted: December 20, 2006
Last Verified: December 2006

Keywords provided by Maxima Medical Center:
Abdominal pain
Appendectomy
Laparoscopy
Chronic appendicitis
Appendicopathy

Additional relevant MeSH terms:
Appendicitis
Abdominal Pain
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive