Condition category
Digestive System
Date applied
09/10/2007
Date assigned
19/10/2007
Last edited
19/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr George Sgourakis

ORCID ID

Contact details

11 Mantzarou Street
Neo Psychiko
Athens
15451
Greece
ggsgourakis@yahoo.gr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This study aims to evaluate the results of hernia sac laparoscopy in cases of spontaneously reduced strangulated hernia content.

Ethics approval

Ethics approval received from the Ethical and Scientific Committee of Red Cross Hospital "Korgialenio-Benakio" on the 31st January 2003.

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Strangulated hernia

Intervention

All patients undergoing an emergency operation for incarcerated inguinal hernia are candidates. In case the hernia contents had spontaneously reduced through the internal inguinal ring definitely before the assessment of the vitality of the contents, patient is randomly assigned in one of two groups:
Group A: patients addressed with the addition of laparoscopy
Group B: patients managed with the regular surgical practice

Randomisation was executed by opening of a sealed envelope. In group A a 10-mm trocar was inserted through the internal inguinal ring and a tight purse-string suture was placed on the hernia sac. A 10-mm laparoscope was inserted to visualise the incarcerated content and assess its viability). In group B, if dark or haemorrhagic fluid was eminent originating from the peritoneal cavity through the open hernia sac, the decision was left to the surgeon for an investigatory midline laparotomy.

The duration of the intervention will continue until 26 patients are enrolled in both groups and follow up will occur one month later after the last patient has been operated (with the present rates of enrolment this may be up to 02/2010).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Major morbidity, measured within 30 days postoperatively
2. Mortality, measured within 30 days postoperatively

Secondary outcome measures

1. Operative time, measured after patient discharge
2. Hours of hospitalisation, measured after patient discharge
3. Days of return to full ordinary and professional activities, measured after the 2 months postoperative follow up

Overall trial start date

01/02/2003

Overall trial end date

01/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 15 - 90 years undergoing an emergency operation due to incarcerated hernia with spontaneous hernia contents reduction before assessment of the strangulated content.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

26 patients per treatment arm (total = 52)

Participant exclusion criteria

1. Poor physical condition not suitable for laparoscopy
2. American Society of Anaesthesiology (ASA) status more than three
3. Denied the randomisation procedure
4. Sepsis at admission
5. A proved direct incarcerated hernia during exploration
6. Incarcerated hernia contents remained in situ (did not reduce spontaneously) until assessment

Recruitment start date

01/02/2003

Recruitment end date

01/02/2010

Locations

Countries of recruitment

Greece

Trial participating centre

11 Mantzarou Street
Athens
15451
Greece

Sponsor information

Organisation

Korgialenio Benakio Red Cross Hospital (Greece)

Sponsor details

2nd Surgical Department
1 Erythrou Stavrou Kai Athanasakh Street
Athens
11526
Greece
karaliotas@korgialenio-benakio.gr

Sponsor type

Hospital/treatment centre

Website

http://www.Korgialenio-Benakio.gr/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes