Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04058223
Collaborator
(none)
2
1
7
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Study Details

Study Description

Brief Summary

The hemorrhoidal disease affects approximately 4.4%-36% of the general population, and it has been estimated that >50% of the population aged >50 years experiences hemorrhoidal problems . Traditional hemorrhoidectomy, including Milligan-Morgan, Ferguson, and Whitehead procedures , are known to cause significant postoperative pain and discomfort and result in a poor quality of life after operation. Since the first introduction of the novel procedure hemorrhoidopexy by Longo in 1998, it has been considered as a safe procedure causing less postoperative pain and resulting in earlier recovery; furthermore, the patients are able to resume their normal daily life and work. The PPH stapler (Ethicon Endo-Surgery, Inc. Cincinnati, OH, USA) was also first introduced in 1998 as a device to perform this procedure. Subsequently, a new device, the DST stapler (Covidien, Mansfield, MA, USA), was introduced in 2008 with some structural differences, including a detachable anvil, three anchor points over different levels, a larger case, and different agraffe sizes.

However, the majority of current studies have been focusing on the use of PPH stapler for hemorrhoidopexy, and comparison with the DST stapler has been rarely discussed. One randomized controlled trial that compared between the PPH stapler and the DST stapler reported that the DST stapler demonstrated a better hemostatic ability and allowed the resection of a larger area of mucosal prolapse; however, that trial focused only on bleeding among the postoperative complications. Currently, only a limited number of studies have compared these two devices in terms of pain, complications, and anorectal stricture incidence rate. The present investigation is a matched cohort-control study aimed to compare the postoperative short-term outcomes among patients with grade III and IV hemorrhoids who were treated with either the PPH or the DST stapler. The specimen surface area and the relationships with complications were also analyzed.

Condition or Disease Intervention/Treatment Phase
  • Device: Hemorrhoidopexy

Study Design

Study Type:
Observational
Actual Enrollment :
2 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Taipei Medical University Shuang-Ho Hospital
Actual Study Start Date :
Sep 5, 2018
Actual Primary Completion Date :
Feb 28, 2019
Actual Study Completion Date :
Apr 5, 2019

Arms and Interventions

Arm Intervention/Treatment
PPH/DST

Patients underwent hemorrhoidopexy by PPH or DST stapler.

Device: Hemorrhoidopexy
stapled hemorrhoidopexy

Outcome Measures

Primary Outcome Measures

  1. Complication [3 months]

    Post-OP bleeding, urinary retention, anaorectal stricture, PPH syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Grade III and grade IV hemorrhoid
Exclusion Criteria:
  • Anal fistula, rectal polyo\p

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Shuang-Ho Hospital New Taipei City Taiwan 235

Sponsors and Collaborators

  • Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Director: Tung-Cheng Chang, MD, PHD, Taipei Medical University Shuang Ho Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tungcheng Chang, Chief of colorectal surgery, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier:
NCT04058223
Other Study ID Numbers:
  • N201808042
First Posted:
Aug 15, 2019
Last Update Posted:
Aug 19, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2019