Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection

NCT ID: NCT02617498

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-11-30

Brief Summary

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Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).

Detailed Description

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Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).

Donors and recipient were followed up after hospital discharge with laboratory investigation, abdominal ultrasound, MRCP in selected cases every month for the first month, then every 6 months and then every year postoperatively. Follow up visits included clinical examination, laboratory investigation, doses of immunosuppressive, radiological examination, and doppler US.

The primary outcome was the amount of blood loss during transection. Secondary outcomes were operative time, time of transection, speed of transection/minutes , number of ligation used, degree of postoperative injury which assessed by daily liver function, WBC, C reactive protein, pathological changes at the cut surface, postoperative morbidity (including biliary leakage, collection), cost and hospital stay.

Conditions

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End Stage Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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harmonic scalpel

parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.

Group Type ACTIVE_COMPARATOR

harmonic scalpel

Intervention Type DEVICE

parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.

spray mode diathermy

parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.

Group Type ACTIVE_COMPARATOR

spray mode diathermy

Intervention Type DEVICE

parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.

Interventions

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harmonic scalpel

parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.

Intervention Type DEVICE

spray mode diathermy

parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.

Intervention Type DEVICE

Other Intervention Names

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Group A Group B

Eligibility Criteria

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Inclusion Criteria

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT

Exclusion Criteria

\-
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ayman El Nakeeb

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman El Nakeeb, MD

Role: STUDY_DIRECTOR

Mansoura University

References

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Salah T, Sultan AM, Fathy OM, Elshobary MM, Elghawalby NA, Sultan A, Yassen AM, Elsarraf WM, Elmorshedi M, Elsaadany MF, Shiha UA, Wahab MA. Outcome of right hepatectomy for living liver donors: a single Egyptian center experience. J Gastrointest Surg. 2012 Jun;16(6):1181-8. doi: 10.1007/s11605-012-1851-4. Epub 2012 Feb 28.

Reference Type RESULT
PMID: 22370735 (View on PubMed)

Wahab MA, Hamed H, Salah T, Elsarraf W, Elshobary M, Sultan AM, Shehta A, Fathy O, Ezzat H, Yassen A, Elmorshedi M, Elsaadany M, Shiha U. Problem of living liver donation in the absence of deceased liver transplantation program: Mansoura experience. World J Gastroenterol. 2014 Oct 7;20(37):13607-14. doi: 10.3748/wjg.v20.i37.13607.

Reference Type RESULT
PMID: 25309092 (View on PubMed)

Sultan AM, Salah T, Elshobary MM, Fathy OM, Elghawalby AN, Yassen AM, Elmorshedy MA, Elsadany MF, Shiha UA, Wahab MA. Biliary complications in living donor right hepatectomy are affected by the method of bile duct division. Liver Transpl. 2014 Nov;20(11):1393-401. doi: 10.1002/lt.23964.

Reference Type RESULT
PMID: 25060964 (View on PubMed)

El Moghazy WM, Hedaya MS, Kaido T, Egawa H, Uemoto S, Takada Y. Two different methods for donor hepatic transection: cavitron ultrasonic surgical aspirator with bipolar cautery versus cavitron ultrasonic surgical aspirator with radiofrequency coagulator-A randomized controlled trial. Liver Transpl. 2009 Jan;15(1):102-5. doi: 10.1002/lt.21658.

Reference Type RESULT
PMID: 19109835 (View on PubMed)

Takatsuki M, Eguchi S, Yamanouchi K, Tokai H, Hidaka M, Soyama A, Miyazaki K, Hamasaki K, Tajima Y, Kanematsu T. Two-surgeon technique using saline-linked electric cautery and ultrasonic surgical aspirator in living donor hepatectomy: its safety and efficacy. Am J Surg. 2009 Feb;197(2):e25-7. doi: 10.1016/j.amjsurg.2008.01.019. Epub 2008 Jul 17.

Reference Type RESULT
PMID: 18639230 (View on PubMed)

Related Links

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http://www.mans.edu.eg/

mansoura university

Other Identifiers

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hepatic transection

Identifier Type: -

Identifier Source: org_study_id

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