Assessment of strangulated content of inguinal hernia spontaneously reduced during induction to anaesthesia through internal inguinal ring laparoscopy
| ISRCTN | ISRCTN78505062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78505062 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/10/2007
- Registration date
- 19/10/2007
- Last edited
- 15/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr George Sgourakis
Scientific
Scientific
11 Mantzarou Street
Neo Psychiko
Athens
15451
Greece
| ggsgourakis@yahoo.gr |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Assessment of strangulated content of inguinal hernia spontaneously reduced during induction to anaesthesia through internal inguinal ring laparoscopy |
| Study objectives | This study aims to evaluate the results of hernia sac laparoscopy in cases of spontaneously reduced strangulated hernia content. |
| Ethics approval(s) | Ethics approval received from the Ethical and Scientific Committee of Red Cross Hospital "Korgialenio-Benakio" on the 31st January 2003. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2003 |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 26 patients per treatment arm (total = 52) |
| Total final enrolment | 41 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- Greece
Study participating centre
11 Mantzarou Street
Athens
15451
Greece
15451
Greece
Sponsor information
Korgialenio Benakio Red Cross Hospital (Greece)
Hospital/treatment centre
Hospital/treatment centre
2nd Surgical Department
1 Erythrou Stavrou Kai Athanasakh Street
Athens
11526
Greece
| karaliotas@korgialenio-benakio.gr | |
| Website | http://www.Korgialenio-Benakio.gr/ |
"ROR" |
https://ror.org/00nnh8h94 |
Funders
Funder type
Other
Investigator initiated and funded (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2009 | 15/07/2021 | Yes | No |
Editorial Notes
15/07/2021: Publication reference and total final enrolment added.
