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Completed

NCT Number: NCT01279551

Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy

This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the postoperative pain related to anorectal spasm (anismus) while performing a stapled haemorrhoidopexy.

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Key information

Conditions

Pain After Stapled Haemorrhoidopexy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome

Rome, 00189, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
  • Adults aged ≤ 75, male or female

Exclusion criteria

  • Concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)

Treatment and study plan

0.4% nitroglycerin ointment

Drug

Local endoanal application 2 times a day

Other names: Rectogesic

lidocaine cloridrato 2.5% ointment

Drug

Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day

Other names: Luan

Primary outcomes

  1. Postoperative pain related to upper anal canal pressure increasing (yes or no)

    Time frame: from the intervention to 1 month

    To evaluate if the pain post stapled haemorrhoidopexy is related to an increased anal resting pressure or not. The presence of anorectal spasm was assessed by clinical examination and anorectal manometry

  2. Postoperative pain remission

    Time frame: from 1 to 90 days after intervention

    To assess postoperative pain remission

  3. Postoperative anal resting pressure at pain remission

    Time frame: from 1 to 90 days after intervention

    We evaluate with anorectal manometry the anal resting pressure at the time of pain remission

Secondary outcomes

  1. Duration of therapy

    Time frame: from 1 to 90 days after intervention

    To evaluate how many days of therapy are needed to obtain pain remission

  2. Use of additional analgesic

    Time frame: from 1 to 90 days to intervention

    To evaluate the use of additional drugs respect to standard therapy

  3. Postoperative pain intensity

    Time frame: from 1 to 90 days after intervention

    To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)

  4. Patients satisfaction

    Time frame: 45 days after intervention

    To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Acronym: TAGASH

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jan 19, 2011
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.