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

NCT04058223 | Completed

• 1 other identifier: N201808042
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Stricture

Outcome Measures

Primary Outcomes (1)

• Complication

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

  3 months

Study Arms (1)

PPH/DST

Patients underwent hemorrhoidopexy by PPH or DST stapler.

Device: Hemorrhoidopexy

Interventions

Hemorrhoidopexy DEVICE

stapled hemorrhoidopexy

PPH/DST

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with grade III and IV hemorrhoid underwent stapled hemorrhoidopexy

You may qualify if:

• Grade III and grade IV hemorrhoid

You may not qualify if:

• Anal fistula, rectal polyo\\p

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

Location

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).

MeSH Terms

Conditions

Hemorrhage; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Tung-Cheng Chang, MD, PHD

  Taipei Medical University Shuang Ho Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of colorectal surgery

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: September 5, 2018
• Primary Completion: February 28, 2019
• Study Completion: April 5, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

TW (1)