Contact information
Type
Scientific
Primary contact
Prof Markus W Büchler
ORCID ID
Contact details
University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
Markus_Buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KSC 02/2003
Study information
Scientific title
Acronym
CLIVIT-Trial
Study hypothesis
To date, no clear scientific recommendation exists in regard to the available blood vessel ligation techniques in thyroid surgery. A systematic review comparing different blood vessel ligation techniques has not yet been performed. The literature on this topic shows several deficits thus reducing its internal and external validity. Main problems are underpowered sample sizes, missing data in regard to the surgical technique, lack of standardization of the various surgical techniques and of homogeneity of the used study designs.
Therefore a randomized controlled multicenter, patient-blinded, two-group parallel relevance study under standardized conditions is required in order to achieve high internal as well as external validity. This would allow the results to be generalized for thyroid surgery and also may have implications for other surgical settings. This study is one of the first studies designed and organized by the Study Center of the German Surgical Society (SDGC). Besides investigating the primary hypothesis, this study was also started with the aim of developing a nationwide structure for randomized trials using a common and surgical relevant procedure.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Thyroid surgery
Intervention
The standard surgical approach in both treatment groups will be the Dunhill-Procedure which consists of a hemithyroidectomy and a subtotal thyroidectomy (at least 2/3 of the gland). The randomisation will proceed when the thyroid gland has been exposed and the decision in favour of a Dunhill procedure is made. Initially the vessels of the upper pole of the thyroid (hemithyroidectomy side) are localised and dissected from medial. Afterwards they are ligated with the conventional clamp-tie technique (Novafil 3-0 or equivalent monofilament suture type). Time is measured from ligating the vessels of the upper pole to the removal of the complete specimen. All vessels except the upper pole vessels of both sides are ligated according to the randomised technique: either using the clip vessel ligation technique or occluding manually by single ligatures (Vicryl 3-0).
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
The primary objective of this study is to test whether there is a relevant reduction in operating time (>15 min), using the clip vessel occluding technique versus the conventional clamp-tie.
Secondary outcome measures
Secondary objectives are divided into surgical and non-surgical categories. In the surgical category there are the following points: total duration of operation (skin incision until suture), weight of specimen, amount of postoperative bleeding, frequency of reoperation due to bleeding, recurrent laryngeal nerve paralysis (temporary or irreversible pre- and postoperative assessment of vocal cord function by ENT-specialist), wound infection rate and rate of impaired parathyroid gland function. The non-surgical category consists of duration of postoperative hospital stay.
To assess the relevance of the chosen endpoints, the following ten aspects have to be ranked from "most important" to "least important" by patients and surgeons (only once): Intraoperative complications, postoperative complications, length of hospital stay, voice function, dysphagia, death, postoperative pain, postoperative fatigue, convalescence of complete physical maximum resilience and cosmetic result.
Overall trial start date
05/03/2004
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
The trial population consists of hospitalised patients of the four participating Departments of Surgery, who are planned for an elective thyroid operation. These operations can be performed with either the clip vessel ligation technique or the conventional clamp-tie technique.
At study enrollment:
Age equal or greater than 18 years
Expected survival time more than 12 months
Patients with benign diseases of the thyroid gland scheduled for elective surgery
Euthyroid metabolism (normal level of TSH or T3/T4)
Normal function of the vocal cords
Informed consent
At the end of surgical exploration:
Suitable for at least 2/3 resection of the thyroid
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
420
Participant exclusion criteria
Malignant disease or high suspicion for malignancy (clinical and imaging evidence)
Nerve palsy
Graves' Disease
Coagulopathy
Current immunosuppressive therapy
Chemotherapy within 2 weeks before operation
Radiotherapy completed no longer than 8 weeks before operation
Severe psychiatric or neurologic disease
Drug- and/or alcohol-abuse
Participation in another intervention-trial with interference of intervention and outcome
Inability to follow the instructions given by the investigator or the telephone interviewer
Lack of compliance
Recruitment start date
05/03/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Germany
Trial participating centre
University of Heidelberg Medical School
Heidelberg
69120
Germany
Sponsor information
Organisation
University of Heidelberg Medical School (Germany)
Sponsor details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
Markus_Buechler@med.uni-heidelberg.de
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Grant from the German Ministry of Research and Education and supported by the BBD-Aesculap© Company, Tuttlingen, Germany
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
1. 2006 study design in http://www.ncbi.nlm.nih.gov/pubmed/16948853
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22729718
Publication citations
-
Study design
Seiler CM, Fröhlich BE, Veit JA, Gazyakan E, Wente MN, Wollermann C, Deckert A, Witte S, Victor N, Buchler MW, Knaebel HP, Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery., Trials, 2006, 7, 27, doi: 10.1186/1745-6215-7-27.
-
Results
Diener MK, Seiler CM, von Frankenberg M, Rendel K, Schüle S, Maschuw K, Riedl S, Rückert JC, Eckmann C, Scharlau U, Ulrich A, Bruckner T, Knaebel HP, Rothmund M, Büchler MW, , Vascular clips versus ligatures in thyroid surgery--results of a multicenter randomized controlled trial (CLIVIT Trial)., Langenbecks Arch Surg, 2012, 397, 7, 1117-1126, doi: 10.1007/s00423-012-0976-y.