- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058223
Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
Taipei Medical University Shuang-Ho Hospital
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 235
- Taipei Medical University Shuang-Ho Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Grade III and grade IV hemorrhoid
Exclusion Criteria:
- Anal fistula, rectal polyo\p
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PPH/DST
Patients underwent hemorrhoidopexy by PPH or DST stapler.
|
stapled hemorrhoidopexy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication
Time Frame: 3 months
|
Post-OP bleeding, urinary retention, anaorectal stricture, PPH syndrome
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Tung-Cheng Chang, MD, PHD, Taipei Medical University Shuang Ho Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201808042
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Bleeding
-
Ethicon, Inc.Guangzhou Bioseal Biotechnology Co., Ltd.Completed
-
Ottawa Hospital Research InstituteRecruitingGastroIntestinal Bleeding | Anticoagulant-induced BleedingCanada
-
Waihong ChungUnknownMetoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy (MANPURSE)Upper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Hyloris DevelopmentsRecruitingBleeding From Teeth | Bleeding ProphylaxisSpain, United States, Belgium, Croatia, Hungary, Romania
-
Ethicon, Inc.CompletedHemorrhage | Soft Tissue Bleeding | Hepatic Parenchyma BleedingUnited Kingdom, Belgium
-
Boston Children's HospitalBaylor College of Medicine; Children's Hospital of Philadelphia; Ann & Robert... and other collaboratorsRecruitingUpper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Wake Forest University Health SciencesCompletedBleeding ComplicationUnited States
-
Chinese University of Hong KongCompletedGastrointestinal Bleeding | Bleeding Peptic Ulcer | Active BleedingChina
-
Chinese University of Hong KongBeijing Friendship Hospital; The First Affiliated Hospital of Soochow University and other collaboratorsCompletedAcute Upper Gastrointestinal Bleeding | Tumor BleedingHong Kong, China, Australia
-
Women and Infants Hospital of Rhode IslandActive, not recruitingAbnormal Uterine Bleeding | Abnormal Uterine Bleeding, Ovulatory Dysfunction | Abnormal Uterine Bleeding, Endometrial Hemostatic DysfunctionUnited States
Clinical Trials on Hemorrhoidopexy
-
Universitätsklinikum Hamburg-EppendorfCompletedInternal Hemorrhoids
-
Medtronic - MITGCompleted
-
National Taiwan University HospitalRecruiting
-
Societa Italiana di Chirurgia ColoRettaleCompletedIII Degree HemorrhoidsItaly
-
Cantonal Hospital of St. GallenActive, not recruitingHemorrhoidsSwitzerland
-
Societa Italiana di Chirurgia ColoRettaleUnknown
-
Larissa University HospitalUniversity of ThessalyCompleted