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

NCT ID: NCT04058223

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2019-04-05

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

PPH/DST

Patients underwent hemorrhoidopexy by PPH or DST stapler.

Hemorrhoidopexy

Intervention Type: DEVICE

stapled hemorrhoidopexy

Interventions

Hemorrhoidopexy

stapled hemorrhoidopexy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Grade III and grade IV hemorrhoid

Exclusion Criteria

• Anal fistula, rectal polyo\p

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tungcheng Chang

Chief of colorectal surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tung-Cheng Chang, MD, PHD

Role: STUDY_DIRECTOR

Taipei Medical University Shuang Ho Hospital

Locations

Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

N201808042

Identifier Type: -

Identifier Source: org_study_id