Pain After Stapled HaemorrhoidopexyPhase 2/3TAGASHNCT01279551

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

A Phase 2/3 study testing 0.4% nitroglycerin ointment and lidocaine cloridrato 2.5% ointment in people with Pain After Stapled Haemorrhoidopexy, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain After Stapled Haemorrhoidopexy
What is being tested?: 0.4% nitroglycerin ointment and lidocaine cloridrato 2.5% ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteItaly
Study dates: Jan 2004to Dec 2010
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
Rome, 00189

Other trials in Italy

About this study

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.

Conditions: Pain After Stapled Haemorrhoidopexy
Being tested: 0.4% nitroglycerin ointment, lidocaine cloridrato 2.5% ointment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.4% nitroglycerin ointmentDrug
Also called Rectogesic
Local endoanal application 2 times a day
lidocaine cloridrato 2.5% ointmentDrug
Also called Luan
Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day

Study groups in NCT01279551
Study group	Role	What they receive
GTN	Experimental	In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg Receives: Drug: 0.4% nitroglycerin ointment
Control	Active comparator	In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg. Receives: Drug: lidocaine cloridrato 2.5% ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative pain related to upper anal canal pressure increasing (yes or no)
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
Measured: from the intervention to 1 month
Postoperative pain remission
To assess postoperative pain remission
Measured: from 1 to 90 days after intervention
Postoperative anal resting pressure at pain remission
We evaluate with anorectal manometry the anal resting pressure at the time of pain remission
Measured: from 1 to 90 days after intervention

Secondary outcomes (4)

Duration of therapy
To evaluate how many days of therapy are needed to obtain pain remission
Measured: from 1 to 90 days after intervention
Use of additional analgesic
To evaluate the use of additional drugs respect to standard therapy
Measured: from 1 to 90 days to intervention
Postoperative pain intensity
To evaluate the intensity of postoperative pain assessed by VAS (visual analogue scale)
Measured: from 1 to 90 days after intervention
Patients satisfaction
To evaluate the satisfaction of the patients, assessed by a questionnaire (scale from 1 to 5)
Measured: 45 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Dec 2010

First posted19 Jan 2011 (estimated)
Study startJan 2004
Primary completionSep 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain After Stapled HaemorrhoidopexyStudies of the same condition, open and under way.
More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01279551
Sponsor's protocol ID: DS-003
Acronym: TAGASH
Status last verified: Jan 2011
First submitted: 18 Jan 2011
Last updated: 25 Jan 2011
Results posted: No

Publications

Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c.
PubMed 23652752

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
ClinicalTrials.gov ID: NCT01279551
Acronym / sponsor ID: TAGASH / DS-003
Conditions: Pain After Stapled Haemorrhoidopexy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of Roma La SapienzaUniversity, hospital or other
Study start: Jan 2004
Primary completion: Sep 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
GTN	Experimental	Drug: 0.4% nitroglycerin ointmentIn this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
Control	Active comparator	Drug: lidocaine cloridrato 2.5% ointmentIn this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.4% nitroglycerin ointmentAlso: RectogesicLocal endoanal application 2 times a day	Drug	GTN
lidocaine cloridrato 2.5% ointmentAlso: LuanLocal endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day	Drug	Control

Primary outcome

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
Postoperative pain remission
Time frame: from 1 to 90 days after intervention
To assess postoperative pain remission
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

4 secondary outcomes

Duration of therapy
Time frame: from 1 to 90 days after intervention
Use of additional analgesic
Time frame: from 1 to 90 days to intervention
Postoperative pain intensity
Time frame: from 1 to 90 days after intervention
Patients satisfaction
Time frame: 45 days after intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
Derived from this study: PubMed 23652752Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francesco Saverio Mari, MD principal investigator

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

Luigi Masoni, MD study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain related to upper anal canal pressure increasing (yes or no) (time frame: from the intervention to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.