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

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.
 
ClinicalTrials.gov Identifier: NCT04058223
Recruitment Status : Completed
First Posted : August 15, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Tungcheng Chang, Taipei Medical University Shuang Ho Hospital

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
Bleeding Stricture Device: Hemorrhoidopexy

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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 : September 5, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Group/Cohort Intervention/treatment
PPH/DST
Patients underwent hemorrhoidopexy by PPH or DST stapler.
Device: Hemorrhoidopexy
stapled hemorrhoidopexy




Primary Outcome Measures :
  1. Complication [ Time Frame: 3 months ]
    Post-OP bleeding, urinary retention, anaorectal stricture, PPH syndrome


Biospecimen Retention:   Samples Without DNA
After the surgery, the ring of the excised anorectal mucosa was cut open and flattened on a surgical towel as shown in Figure 2. The presence of muscle in the specimen was confirmed grossly and photographed. The entire surface area of the mucosa, muscle and the muscle/mucosa ratio were measured using the ImageJ software (National Institutes of Health, Bethesda, MD, USA).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with grade III and IV hemorrhoid underwent stapled hemorrhoidopexy
Criteria

Inclusion Criteria:

  • Grade III and grade IV hemorrhoid

Exclusion Criteria:

  • Anal fistula, rectal polyo\p

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): NCT04058223


Locations
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Taiwan
Taipei Medical University Shuang-Ho Hospital
New Taipei City, Taiwan, 235
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Study Director: Tung-Cheng Chang, MD, PHD Taipei Medical University Shuang Ho Hospital

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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: August 15, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical