NCT04058223

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

Completed Last updated 19 August 2019

What this trial tests

trial testing Hemorrhoidopexy in Bleeding in 2 participants. Completed in 5 April 2019.

Timeline

5 September 2018

Primary endpoint
28 February 2019

5 April 2019

Quick facts

Lead sponsor	Taipei Medical University Shuang Ho Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2
Start date	5 September 2018
Primary completion	28 February 2019
Estimated completion	5 April 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• Hemorrhoidopexy

Conditions studied

• Bleeding — all drugs for Bleeding →
• Stricture — all drugs for Stricture →

Sponsor

Taipei Medical University Shuang Ho Hospital

Who can join

Adults 18 to 99, any sex, with Bleeding or Stricture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.